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高频针状手术电极头 - NMPA Registration 闽械注准20242010215

Access comprehensive regulatory information for 高频针状手术电极头 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20242010215 and owned by Double Medical Technology Inc.. The device was approved on November 21, 2024.

This page provides complete registration details including registrant information, province location (Fujian), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data
Class II
闽械注准20242010215
高频针状手术电极头
NMPA Registration Number: 闽械注准20242010215
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Pricing
Intended Use
English

与高频手术设备配套,供临床各类开放性外科手术中用于组织切割、凝固..

中文

与高频手术设备配套,供临床各类开放性外科手术中用于组织切割、凝固。.

Device Classification
Device Class
Class II
Model Specifications
See annex
见附件
Approval Department
Fujian Provincial Drug Administration
福建省药品监督管理局
Registration Information
Registration Number
闽械注准20242010215
Approval Date
November 21, 2024
Expiry Date
November 20, 2029
Registrant
Name
Double Medical Technology Inc.
大博医疗科技股份有限公司
Province/Region
Fujian
福建
Address
No. 18, Hongdong Road, Shanbian District, Haicang District, Xiamen
厦门市海沧区山边洪东路18号
Production Facility
Production Address
厦门市海沧区山边洪东路18号主厂区,18-4号一层A区、二层、三层、四层A区;厦门市海沧区湖头路17-1号一层、三层,17-2号一层A区、二层
Structure and Composition
English

产品由电极头和手柄组成,手柄由绝缘保护套和不锈钢组件组成,产品经环氧乙烷灭菌,应无菌..

中文

产品由电极头和手柄组成,手柄由绝缘保护套和不锈钢组件组成,产品经环氧乙烷灭菌,应无菌。.

Additional Information
Appendix
产品技术要求